NCT05582174 PPI Infusion Versus Oral Acid Pump Inhibitors for Bleeding Peptic Ulcers
| NCT ID | NCT05582174 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chinese University of Hong Kong |
| Condition | Upper GI Bleeding |
| Study Type | INTERVENTIONAL |
| Enrollment | 594 participants |
| Start Date | 2023-05-18 |
| Primary Completion | 2028-01-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 594 participants in total. It began in 2023-05-18 with a primary completion date of 2028-01-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Vonoprazan (VPZ), an oral potassium-competitive acid blocker (P-CAB) has emerged as an alternative potent acid-suppressant.It has a faster onset of action in 1 day (3-5 days in PPI), and is more stable in acidic condition than PPI. While many studies compared Vonoprazan against PPI in the treatment of reflux oesophagitis, H. Pylori eradication, and gastric ulcers; thus far, there is a paucity of data on use of Vonoprazan on bleeding peptic ulcers. We perform a multicenter randomized controlled trial (RCT) to compare the efficacy of oral Vonoprazan against standard high dose PPI therapy in bleeding peptic ulcers that had received successful endoscopic haemostasis We hypothesize that in patients with bleeding peptic ulcers, the use of acid pump inhibitors Vonoprazan would not be inferior to standard treatment of a bolus plus high dose PPI intravenous infusion at preventing recurrent bleeding after endoscopic haemostasis.
Eligibility Criteria
Inclusion Criteria: * \- Patients aged ≥18 years who had undergone oesophagogastroduodenoscopy (OGD) for sign and symptoms of aneamia or upper GI bleeding including haematochezia, melaena or haematemesis, and found to a non-variceal upper GI cause of bleeding (peptic ulcers, dieulafoy's lesions, Mallory Weiss tear with active bleeding or major stigmata of haemorrhage * Major stigmata of recent haemorrhage includes peptic ulcers with spurting or oozing bleeding (Forrest classification Ia and Ib, respectively) ,with a nonbleeding visible vessel (Forrest classification IIa) or an adherent clot (Forrest classification IIb). For peptic ulcers with an adherent clot (Forrest classification IIb), the clot would be lifted (by irrigation using syringe boluses or water pump device, or manipulation with a snare or alligator etc.) and ulcer base examined to look for underlying vessels. Once the clot is removed, any identified underlying active bleeding or nonbleeding visible vessel should receive endoscopic haemostasis * Patients who had undergone endoscopic hemostatic treatment (a combination of hemoclipping therapy or contact thermocoagulation using multipolar/bipolar electrocautery probes or haemostatic forceps, with or without preinjection of diluted epinephrine. Endoscopic haemostasis is defined as no evidence of bleeding after irrigation and 3 minutes of observation Exclusion Criteria: * No consent * Patients under the age of 18 * Patients who were pregnant or in lactation * Hypersensitivity to PPI or Vonoprazan or any component of the formulation * Patients who were found to have tumour bleeding, oesophageal varices as the cause of the NVGIB * NVGIB due to post therapeutic endoscopic treatment such as gastric polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection etc.
Contact & Investigator
Side Liu, PhD
STUDY DIRECTOR
Southern Medical University, China
Frequently Asked Questions
Who can join the NCT05582174 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Upper GI Bleeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05582174 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05582174 currently recruiting?
Yes, NCT05582174 is actively recruiting participants. Contact the research team at luoxiaobei63@126.com for enrollment information.
Where is the NCT05582174 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China, Guangzhou, China, Shenzhen, China and 4 additional locations.
Who is sponsoring the NCT05582174 clinical trial?
NCT05582174 is sponsored by Chinese University of Hong Kong. The principal investigator is Side Liu, PhD at Southern Medical University, China. The trial plans to enroll 594 participants.